NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial

1620125

A Randomized, Double-blind, placebo-controlled Trial to Evaluate the Efficacy of Oral Nam for the Prevention of Acute Kidney Injury in Patients Undergoing On-Pump Cardiac Surgery

2021-09-13

2025-04-30

2025-06-30

Recruiting

Early phase I

304

Inclusion Criteria * Informed consent before any study-related activities. * Men or women \>18 years of age who are scheduled for non-emergent cardiac surgery procedures requiring CPB and are at increased risk for surgery-related adverse cardiovascular outcomes. Procedures include: * CABG * Aortic, mitral, tricuspid, or pulmonic valve replacement or repair * CABG with aortic, mitral, tricuspid, and/or pulmonic valve replacement Risk factors for surgery related to adverse cardiovascular outcomes include one or more of the following: * Valve surgery * eGFR \< 45 ml/min/1.73m2 * Documented LVEF ≤ 35% within six months before surgery * Documented history of heart failure * Insulin-requiring diabetes * Non-insulin-requiring diabetes and the presence of ≥+2 proteinuria on urinalysis (or equivalent on urine protein-to-creatinine ratio or urine albumin-to-creatinine ratio) * Preoperative anemia (hemoglobin \<11g/dl for men and women) * History of prior CABG * Age ≥65 Exclusion Criteria * Preexisting AKI within seven days before surgery as defined by KDIGO stage ≥1 (serum creatinine-based) * Kidney transplant status * Off-pump cardiac surgery * ESRD * Emergent cardiac surgery * Pregnancy * Patient enrolled in competing research studies that may affect outcomes * Patients held in an institution by legal or official order

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 304, 'type': 'ESTIMATED'}}

2023-07-18